Duns Number:831737957
Device Description: 11 GA X 4" Double Diamond J-Type Bone Needle With 14 GA Extraction Cannula
Catalog Number
BMNJ-MEC-1110
Brand Name
MPM Medical Supply (Private Label)
Version/Model Number
BMNJ-MEC-1110
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K890925,K890925,K890925
Product Code
DWO
Product Code Name
Needle, Biopsy, Cardiovascular
Public Device Record Key
8c4323ed-8699-4ece-b3b5-fc56c863c53e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 12, 2017
Package DI Number
10859013006007
Quantity per Package
5
Contains DI Package
00859013006000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvek Pouches
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |